Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
K-Number: K160367 · 2016-07-27
ApplicantNissin-Metec China Co., Ltd.
Decision Date2016-07-27
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is a medical device manufactured by Nissin-Metec China Co., Ltd.. It received FDA 510(k) clearance on 2016-07-27 under approval number K160367. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank?
Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is a medical device that received FDA 510(k) clearance on 2016-07-27. It is manufactured by Nissin-Metec China Co., Ltd.. The 510(k) number is K160367.
When was Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank approved by the FDA?
Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank received FDA 510(k) clearance on 2016-07-27, under approval number K160367.
What company makes Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank?
Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is manufactured by Nissin-Metec China Co., Ltd..
What is the FDA product code for Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank?
The FDA product code for Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is EIH.
Related Clinical Trials
Related Devices (Code: EIH)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.